Extractables & Leachables

Pine Lake Laboratories is the scientific leader in extractables and leachables (E&L) studies. We have extensive experience with pharmaceutical container closures, single use system components, and combination devices. Our experienced scientific staff utilizes the following analytical methods for expert identification of extractables observed in a forced extraction study.

Bioanalytical, Preclinical, Clinical

We provide bioanalytical methods development, validation andsample analysis in our FDA-GLP registered facility in Bristol, CT. We support all types of preclinical studies from early discovery (ADME, PK, TK) through long-term chronic in all species. Pine Lake Labs Research group has many years of methods development experience in complex matrices such as brain, spleen,spinal cord and vaginal tissue, in addition to the traditional matrices ofblood, plasma and urine.

Analytical Testing of Combination Products

Pine Lake Laboratories has a proven track record in developing and validating methods used to insure the quality of combination devices, especially combination pharmaceutical medical devices. Our experience allows us to adapt validation strategies and assist in testing designs to meet the unique challenges of combination devices.

Nitrosamine Analysis

Pine Lake laboratories can perform the nitrosamine impurities analyses following the FDA published methods for Losartan, Valsartan, Metformin, Ranitidine, Rifampin, Rifapentine and Varenicline.   For additional drugs, we can perform the risk assessment, nitrosamine analysis and toxicological risk assessment for the specific drug product.   Our materials expert will identify all of the potential sources of nitrosamines.   Once the targeted nitrosamines have been identified, our GMP analytical team can develop and validate sensitive GC-MS and LC-MS/MS methods for nitrosamines in any API or drug products.   Finally, we can support the final results with a toxicological risk assessment when needed.

CMC Analytical Testing

Pine Lake Laboratories has a proven track record in developing and validating methods used to insure the quality of active pharmaceutical ingredients (API) and finished drug products. Our experience allows us to adapt validation strategies and assist in testing designs to meet any unique challenges presented by a new drug in development.

Short Chain Fatty Acid Analysis

We have developed a method for the analysis of short chain fatty acids in feces to support microbiome research. The method analyses for acetic acid, propionic acid and butyric acid in dried feces. The method feature a sample extraction followed by analysis by GC-MS and uses stable isotopelabeled internal standard. The method has been used successfully in rat, dog and human feces.

Address
719 Middle St, Bristol, CT 06010
Call Us
(860) 940 - 6550
Email Us
info@pinelakelabs.com